The following data is part of a premarket notification filed by Hycel, Inc. with the FDA for Hycel Counter 211.
| Device ID | K782102 |
| 510k Number | K782102 |
| Device Name: | HYCEL COUNTER 211 |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | HYCEL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-12-18 |
| Decision Date | 1979-01-03 |